Healia Clinical Trials Information Database

Mucosal Immunotherapy for Peanut Allergy

The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.

Description

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut mucosal immunotherapy (MIT). We are also studying the effect of peanut MIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six with peanut allergy will be randomized to peanut MIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the DCRU. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut MIT using appropriate statistical analysis.

Status: Active, not recruiting (N/A). Started on March 1st, 2007.

Enrollment: 45 subjects

Study Type: Interventional

Study Design:

  • Allocation: Randomized
  • Endpoint Classification: Safety/Efficacy Study
  • Intervention Model: Crossover Assignment
  • Masking: Double Blind (Subject
  • Caregiver
  • Investigator)
  • Primary Purpose: Treatment

Conditions:

Interventions:

  • Other: Peanut flour
  • Dietary Supplement: Oat
  • Other: Peanut flour

Eligibility

Inclusion Criteria:

  • Subject between 1 and 6 years of age

  • Diagnosed peanut allergy by RAST greater than or equal to 15 within past 6 months and have eaten peanut in diet resulting in a clinical reaction prior to diagnosis

  • Diagnosed peanut allergy by RAST greater than or equal to 7 within past 6 months and have had a clinical reaction to peanut ingestion within the past 6 months

Exclusion Criteria:

  • Subjects with a history of severe, anaphylaxis to peanut

  • Medical history that would prevent a DBPCFC/OFC to peanut

Gender

Both

Mininum Age

1 Year

Maximum Age

7 Years

Healthy Volunteers

No


Resources

Source: Duke University

Authority: United States: Food and Drug Administration

Locations

  • University of Arkansas Medical Center
    Little Rock
    Arkansas
    72202
    United States

Officials

  • Arvil W Burks, MD (Principal Investigator, Duke University)

Sponsors

  • Duke University (Lead Sponsor)

  • University of Arkansas (Collaborator)

References

None.

Links

None.


Date Verified
May 1st, 2011
First Received
May 5th, 2011
Last Changed
May 5th, 2011

Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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